Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that now needs treatment again, and who previously had at least a partial response to treatment with venetoclax-rituximab or venetoclax-obinutuzumab as part of specific earlier studies (HOVON 139/GIVE or HOVON 140/GAIA)
• People whose general health and ability to carry out daily activities falls within an acceptable range as measured by a standard medical scale (a score of 0–3, with a score of 3 only accepted if the reduced function is caused by the CLL itself)
• People aged 18 years or older
• People whose bone marrow is functioning at a minimum acceptable level, based on blood counts for red blood cells, infection-fighting white blood cells, and platelets (confirm specific values with trial site)
• People whose kidneys are filtering blood at a sufficient rate (confirm specific threshold with trial site)
• People whose liver is functioning within acceptable limits based on standard blood tests (confirm specific values with trial site)
• People whose blood clotting levels are within an acceptable range on standard tests (confirm with trial site)
• People who test negative for hepatitis B and hepatitis C viruses, or who test positive on an initial screen but negative on a more sensitive follow-up test within 6 weeks before joining
• People who are willing and able to attend scheduled study visits and follow the study requirements
• People who are able to understand the study and give their informed consent in writing

Who may not be able to join:

• People who have previously been treated with a BTK inhibitor (a type of targeted cancer medicine)
• People who have received venetoclax at any time other than as a first treatment
• People who have received other types of treatments, with the exception of certain chemotherapy or immunotherapy received after a first-line venetoclax relapse
• People whose CLL has transformed into a more aggressive type of lymphoma (known as Richter's transformation)
• People who have a history of a confirmed brain infection called progressive multifocal leukoencephalopathy (PML)
• People who currently have another cancer that requires treatment, has not been treated with the aim of cure, or has shown signs of returning after curative treatment
• People with a known allergy to medicines called xanthine oxidase inhibitors or rasburicase (medicines used to manage a complication called tumour lysis syndrome)
• People who have had a severe allergic reaction to any of the medicines used in this trial
• People who are currently experiencing active bleeding or have a history of a bleeding disorder such as haemophilia or von Willebrand disease
• People with an active bacterial, fungal, or viral infection that requires treatment
• People with serious or poorly controlled ongoing medical conditions, such as uncontrolled infection, certain immune-related blood conditions, diabetes, high blood pressure, or thyroid disorders
• People known to be living with HIV
• People who need to take certain medicines that interact with the study drugs, including specific blood thinners such as warfarin or similar vitamin K-blocking medications (confirm specific medicines with trial site)
• People who have had a stroke or bleeding in the brain within the 6 months before registering for the trial
• People with serious heart conditions such as certain irregular heart rhythms, heart failure, significant heart disease, or a heart attack within the past 6 months
• People with severe lung problems
• People with severe neurological or psychiatric illness
• People who have difficulty swallowing tablets or who have significant digestive conditions that could affect how medicines are absorbed
• People who have received a live vaccine within 28 days before registering
• People who have taken part in another experimental drug study within 28 days before registering
• People who have had major surgery within 28 days before registering
• People who have used steroid medicines (with some specific exceptions) within 10 days before registering (confirm details with trial site)
• People who are pregnant or breastfeeding
• People who are able to have children and are not willing to use a highly effective method of contraception during treatment and for 30 days after treatment ends, unless they have been surgically sterilised or have been through menopause for at least 2 years
• People currently participating in another clinical trial, other than the follow-up phase of the HOVON 139 or HOVON 140 studies
• People whose personal, psychological, family, or geographic circumstances may make it difficult to follow the study schedule and requirements

Important: Always verify eligibility with the trial site directly before applying.